Cross-pin graft fixation, instruments, and methods

ABSTRACT

A two piece graft fixation arrangement includes a graft block engageable with a graft and a transverse member engageable with the graft block to fix the graft block in a bone tunnel. Instruments and methods are presented for installing a graft in a bone tunnel and anchoring the graft with a transverse member placed through a transverse bore intersecting the bone tunnel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent application Ser. No. 10/693,464, filed Oct. 24, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/658,052, filed Sep. 9, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/438,510, filed May 15, 2003 which claims the benefit of U.S. Provisional Application No. 60/380,376 filed May 15, 2002, and U.S. Provisional Application No. 60/423,022 filed Nov. 1, 2002.

FIELD OF THE INVENTION

The invention relates to soft tissue repair and reconstruction. More particularly, the invention relates to the fixation of a graft within a bone tunnel. Still more particularly, the invention relates to improvements in the use of a transverse pin to retain a graft within a bone tunnel.

DESCRIPTION OF THE PRIOR ART

The repair and reconstruction of torn or damaged soft tissues is a common surgical procedure. For example, replacement graft ligaments may be secured at the site of the original ligament. The procedure generally involves drilling bone tunnels into adjacent bones at the site of the original ligament and securing within these bone tunnels a graft ligament. In many applications, such as in the knee joint, such procedures may be performed arthroscopically. The graft ligament may be an autograft, an allograft, a xenograft, and/or it may be totally artificial and synthetic. The most common types of graft ligaments include ones which may be bone-tendon-bone or soft tissue (such as semitendinosus and gracilis tendons), both types harvested by techniques well known to those skilled in the art.

The graft ligaments are secured within the bone tunnels in a variety of ways. Of prime importance is the degree to which they can withstand pullout forces prior to complete healing. For example, it is known to use interference screws inserted parallel to the tunnel axis to compress the ends of the graft ligament against the walls of the bone tunnel to secure the graft ligament and promote tissue in-growth.

Recently, cross-pin fixation devices have been developed to retain the graft ligament within the bone tunnel by securing it with a pin extending transversely through the tunnel and the ligament. Cross-pin fixation, although a more complex procedure, generally provides the highest pullout forces.

Various methods are known to achieve cross-pin fixation. All methods require the initial formation of the ligament bone tunnel in the tibia and femur in a conventional manner. All methods also end up with a pin situated transversely through the graft ligament. (As used herein, (1) in the case of a bone-tendon-bone graft, “through” means actually through the bone at one end of the graft and (2) in the case of a soft tissue graft, “through” means the graft ligament is folded over on itself and the pin extends between the folded ligament strands.) The differences between the various cross-pin fixation methods lies primarily in the manner in which the graft ligament is engaged with the cross-pin. One method utilizes bone-tendon-bone grafts and involves pushing or pulling one of the bone ends of the graft into the femoral tunnel and drilling a transverse hole in the femur to place a cannulated pin directly and transversely through the bone end. U.S. patents representative of this method include the following: U.S. Pat. No. 5,004,474 (Frank et al.); U.S. Pat. Nos. 5,350,380, 5,354,300, 5,397,356, 5,431,651 (FIG. 7, 7A), U.S. Pat. No. 5,562,671 (all to Goble et al.); U.S. Pat. No. 5,688,284 (Chervitz et al.); U.S. Pat. No. 6,066,173 (McKernan et al.) and U.S. Pat. No. 6,113,604 (Whittaker et al.).

This method may be further understood by reference to aforementioned U.S. Pat. No. 5,350,380 (Goble et al.) which shows a bone drill for drilling a ligament bone tunnel from the proximal tibial surface into the femur. The bone drill is used in conjunction with a C-shaped drill guide to position the location of a transverse hole to be drilled through the lateral femoral surface in order to intersect the ligament bone tunnel at a predetermined location. The graft is pulled into the ligament bone tunnel by sutures extending through the tunnel and a tapered transverse pin is screwed into place to secure the graft.

Another method utilizes soft tissue grafts and involves folding the strands of graft material to create a bundle and pushing the bundle into the femoral tunnel. A cannulated guide pin is placed through the graft ligament strands (i.e. at the fold). U.S. patents representative of this method are U.S. Pat. No. 5,601,562 (Wolf et al.) and U.S. Pat. No. 6,306,138 (Clark et al.)

This method may be further understood by reference to aforementioned U.S. Pat. No. 5,601,562 (Wolf et al.) which discloses a way of pushing a soft tissue graft ligament into a bone tunnel using a notched ligament inserter. A guide wire is then drilled transversely through one of the pair of notches on the inserter to enable a guide pin to be situated within the loop formed by the soft tissue graft. A cannulated cylindrical cross-pin implant is placed over the guide pin and advanced through the transverse tunnel and into the femur on the opposite side of the tunnel to complete the fixation.

Another method also utilizes soft tissue grafts but requires attaching a suture to one end of the graft, placing a loop of the suture in the bone tunnel at the site wherein the transverse pin will be placed, advancing a transverse guide wire or pin through the loop of suture and then pulling or threading the graft over the pin or guide wire (if the latter, then advancing a cannulated pin over the guide wire) to form a fold in the graft ligament. U.S. patents representative of this method are: U.S. Pat. No. 5,266,075 and U.S. Pat. No. 5,393,302 (both to Clark et al.); U.S. Pat. No. 5,431,651 (FIG. 7B, 7C to Goble); and U.S. Pat. No. 5,674,224 (Howell et al.).

The method may be further understood by reference to aforementioned U.S. Pat. No. 5,393,302 (Clark et al.) which discloses a method of inserting a soft tissue graft ligament by pushing it into the bone tunnel on a tendon threader having orthogonally oriented slots at its distal end. One pair of opposed slots engages the graft ligament (or suture secured to the graft ligament) in order to position it at the end of the ligament bone tunnel. A transverse pin may then be drilled directly through the other set of opposed slots. The graft ligament can then be looped over the transverse pin.

Another method also utilizes soft tissue grafts but requires a transverse tunnel entirely through the femur at a point intersecting the ligament bone tunnel. A flexible guide wire is placed in the transverse tunnel and its middle portion is pulled out of the ligament bone tunnel entrance forming a guide wire loop. The soft tissue graft ligament is passed through the guide wire loop and folded back on itself. By pulling in opposite directions on the ends of the flexible guide wire, the graft is pulled into place. The guide wire is then used to guide a cannulated cross-pin into place under the graft ligament fold. U.S. patents representative of this method are U.S. Pat. No. 5,895,425 (Grafton et al.) and U.S. Pat. Nos. 5,918,604 and 6,132,433 (both to Whelan). This method may be further understood by reference to aforementioned U.S. Pat. No. 5,895,425 (Grafton et al.) which shows that, after the formation of the ligament bone tunnel, a transverse bone tunnel is formed entirely through the femur intersecting the end of the ligament bone tunnel at which the graft is to be placed. A flexible guide wire is threaded through this transverse bone tunnel. The central portion of this flexible guide wire is pulled out of the ligament bone tunnel until it is completely outside the body. A soft tissue ligament graft is looped around this flexible guide wire. The ends of the flexible guide wire are then pulled away from each other to draw the flexible guide wire and the looped graft ligament into the ligament bone tunnel. A cannulated transverse pin is then drilled into place across the ligament bone tunnel and the flexible guide wire is withdrawn.

It is also known that the transverse pin need not be exactly perpendicular to the ligament bone tunnel. U.S. Pat. No. 5,688,284 (Chervitz et al.) shows, for example, a variable angle drill guide which enables the transverse pin to be oriented at a desired angle relative to the ligament bone tunnel.

U.S. Pat. No. 6,066,173 (McKeman et al.) shows another method of cross-pinning fixation utilizing a plurality of transverse pins inserted through the ligament within the ligament bone tunnel.

All known cross-pin fixation systems have some disadvantages and it is an object of this invention to overcome these disadvantages. In the case of the first three methods it is difficult and time consuming to place the transverse pin and thread the graft ligament over the cross-pin or guide pin. In the case of the last method, pulling in opposite directions to move a graft perpendicular to the pulling directions is difficult and the flexible guide wire can be kinked or severed by the cross-pin. In the methods involving pushing the graft ligament into place, the diameter of the ligament bone tunnel must be larger than desired in order to accommodate the dimensions of the pusher and the graft ligament such that when the pusher is removed, the bone tunnel is over-sized relative to the graft.

SUMMARY

The present invention provides a graft retaining system for retaining a graft in a bone tunnel.

In one aspect of the invention, a drill guide assembly for drilling a hole in a bone and for maintaining alignment with the hole includes a drill, a drill sleeve and a cannula. The cannula is slidingly engageable with the drill sleeve, such that it may be disengaged from the drill sleeve to maintain the location of the hole in the bone.

In another aspect of the invention, a transverse member alignment instrument is provided for use with a transverse member having a distal portion including a first cylindrical portion, a proximal portion having a second cylindrical section having a diameter larger than the first cylindrical section, and a shoulder formed between the first and second cylindrical sections. The transverse member is transversely engageable with a graft block to maintain a ligament in a bone tunnel. The transverse member alignment instrument includes a distal portion including a first cylindrical section corresponding to the transverse member, a proximal portion having a second cylindrical section having a diameter larger than the first cylindrical section corresponding to the transverse member, a shoulder formed between the first and second cylindrical sections corresponding to the transverse member, and a handle formed adjacent to the proximal portion.

In another aspect of the invention, a transverse member is provided for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel. The transverse member includes a distal portion having an axis, a distal end, a proximal end, and an outer surface; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole by pushing the transverse member axially into the transverse bone hole; and an eyelet formed transversely through the distal portion.

In another aspect of the invention, a transverse member is provided for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel. The transverse member includes a distal portion having an axis, a distal end, a proximal end, and an outer surface; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole; and a slot formed in the distal portion, the slot angling distally from the outer surface of the distal portion toward the axis.

In another aspect of the invention, a transverse member is provided for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel. The transverse member includes a distal portion having an axis, a distal end, a proximal end, and an outer surface, the distal portion being threaded adjacent the distal end; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole; and a guide member including an elongated body having a first end, a second end, and an axis extending therebetween, the guide member being threaded adjacent the first end, the first end being threadingly engageable with the distal portion.

In another aspect of the invention, a method is provided for forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel. The method includes forming a graft tunnel in the bone; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and positioning a second leg outside of the bone, the second leg having a transverse drill sleeve directed transverse to the graft tunnel; mounting a cannula on the drill sleeve in sliding relationship; guiding a drill bit with the drill sleeve to form a transverse bone hole intersecting the graft tunnel; and advancing the cannula into engagement with the transverse bone hole to maintain access to the transverse bone hole upon removal of the drill guide.

In another aspect of the invention, a method is provided for forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel. The method includes forming a graft tunnel in the bone; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and positioning a second leg outside of the bone, the second leg having a transverse drill sleeve directed transverse to the graft tunnel; advancing a drill transversely along the drill sleeve axis until the distal end of the drill contacts the outer surface of the bone; reading indicia on the drill bit to determine the distance from the outer surface of the bone to the graft tunnel; and advancing the drill bit into the bone to form a transverse bone hole intersecting the graft tunnel.

In another aspect of the invention, a method is provided for inserting a transverse member in a transverse bone hole to intersect a graft tunnel to secure a graft in the tunnel. The method includes inserting a guide member through the transverse bone hole and across the graft tunnel; engaging an inserter with a proximal end of a transverse member; and pushing the transverse member into the transverse bone hole while simultaneously tensioning the guide member to guide the tip of the transverse fixation member across the graft tunnel.

In another aspect of the invention, a method is provided for securing a graft in a graft tunnel, the graft being attached to a graft block having a transverse aperture alignable with a transverse bone hole, the graft block being fixed in the graft tunnel by a transverse member insertable along the transverse bone hole and through the aperture to suspend the graft block and graft in the graft tunnel. The method includes providing a transverse member alignment instrument; inserting the transverse member alignment instrument along transverse bone hole and into engagement with the graft block aperture; removing the transverse member alignment instrument; and inserting the transverse member into engagement with the graft block.

In another aspect of the invention, a method is provided for forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel. The method includes inserting a guide wire into a bone along the desired path of a graft tunnel for receiving a ligament graft; forming a graft tunnel in the bone by advancing a cannulated drill over the guide wire; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and extending a second leg along the outside of the bone parallel to the first leg; directing a drill sleeve mounting on the second leg transversely toward the graft tunnel; mounting a cannula on the drill sleeve in sliding relationship; advancing a drill transversely along the drill sleeve axis until the distal end of the drill contacts the outer surface of the bone; reading indicia on the drill bit to determine the distance from the outer surface of the bone to the graft tunnel; advancing the drill bit into the bone to form a transverse bone hole intersecting the graft tunnel; advancing the cannula into engagement with the transverse bone hole to maintain access to the transverse bone hole upon removal of the drill guide; inserting a suture passing pin through the first leg of the drill guide, along the graft tunnel, and through the bone along the graft tunnel axis; removing the drill guide; threading a graft passing suture up through the graft tunnel and out of the bone using the suture passing pin; lifting the graft into the graft tunnel using the sutures; inserting a guide member through the access cannula, through the graft block; and out of the bone; engaging an inserter with the proximal end of the transverse fixation member; and pushing the transverse fixation member into the transverse bone hole while simultaneously tensioning the guide member to guide the tip of the transverse fixation member through the graft block.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will be discussed with reference to the appended drawings. These drawings depict only illustrative embodiments of the invention and are not to be considered limiting of its scope.

FIG. 1 is a perspective view of a human knee joint showing the insertion of a graft block and cross-pin according to the present invention.

FIG. 2 is a detail view taken from FIG. 1.

FIG. 3 is perspective view of an alternative embodiment of the graft block of FIG. 1.

FIG. 4 is a perspective view of an alternative embodiment of the graft block of FIG. 1.

FIG. 5 is a perspective view of an alternative embodiment of the cross-pin of FIG. 1.

FIG. 6 is an exploded perspective view of an alternative embodiment of the graft block of FIG. 1.

FIG. 7 is a perspective view of the graft block of FIG. 6.

FIG. 8 is a perspective view of an alternative cap used in conjunction with the graft block of FIG. 6.

FIG. 9 is a perspective view of a tunnel drill bit according to the present invention.

FIGS. 10 and 11 are exploded perspective views of an illustrative set of surgical instruments according to the present invention.

FIG. 12 is a cross sectional view taken along line 12-12 of FIG. 10.

FIG. 13 is a cross sectional view taken along line 13-13 of FIG. 10.

FIG. 14 is a detail view take from FIG. 10.

FIGS. 15-20 are perspective views of a human knee joint showing an illustrative method of using the instruments of FIGS. 9-11.

FIG. 21 is a perspective view of the assembled instruments of FIGS. 9-11 showing an alternative transverse depth measuring arrangement.

FIG. 22 is a perspective view of the assembled instruments of FIGS. 9-11 showing an alternative transverse depth measuring arrangement.

FIG. 23 is a perspective view of the graft block of FIG. 1 showing an optional loop attachment mechanism.

FIG. 24 is a section view taken along line 10-10 of FIG. 23.

FIG. 25 is a perspective view of a human knee joint showing the insertion of an alternative embodiment of a graft block according to the present invention.

FIG. 26 is a perspective view of the graft block of FIG. 25.

FIG. 27 is a side plan view of the graft block of FIG. 25.

FIG. 28 is a front plan view of the graft block of FIG. 25.

FIG. 29 is a top plan view of the graft block of FIG. 25.

FIG. 30 is a perspective view of a pushing member for use with the graft block of FIG. 25.

FIG. 31 is an exploded perspective view of an illustrative set of surgical instruments similar to FIG. 11 and including alternative configurations for some of the instruments.

FIG. 32 is a partial cross-sectional view taken along line 32-32 of FIG. 31 illustrating an access cannula.

FIG. 33 is an exploded perspective view of a portion of the set of surgical instruments of FIG. 31 showing an alternative configuration of the access cannula and drill guide base.

FIG. 34 is a perspective view of an instrument according to the present invention.

FIG. 35 is a perspective view of a transverse member alignment instrument according to the present invention.

FIG. 36 is a top plan view of a transverse member and driver according to the present invention.

FIG. 37 is a side elevation view of the transverse member of FIG. 36.

FIG. 38 is a cross sectional view of the transverse member of FIG. 36 taken along line 38-38.

FIG. 39 is a top plan view of the transverse member of FIG. 36 showing an alternative arrangement for attaching a guide member.

FIG. 40 is a cross sectional view of the transverse member of FIG. 39 taken along line 40-40.

FIG. 41 is an elevation view of the end of the transverse member of FIG. 36 showing an alternative arrangement for attaching a guide member.

FIG. 42 is an elevation view of the end of the transverse member of FIG. 36 showing an alternative arrangement for attaching a guide member.

FIG. 43 is a perspective view of the end of the transverse member of FIG. 36 showing an alternative arrangement for attaching a guide member.

FIGS. 44-50 are partially sectioned perspective views showing the instruments and implants of the present invention in use with a human knee.

DETAILED DESCRIPTION

Embodiments of a two piece cross-pin graft system include a graft block sized to fit within a bone tunnel and fixation means for fixing the graft block within the bone tunnel. The graft fixation system may be used to attach any appropriate graft including for example supplemental and/or replacement grafts for the soft tissues associated with the skeletal system. For example, the system may be used to replace soft tissues associated with skeletal joints such as the hip, knee, shoulder, wrist, elbow, ankle, vertebral, phalangeal, temporomandibular, and other joints and locations within a body. For example, the graft fixation system may be used to attach, within a bone tunnel, grafts associated with human knee joint tissues such as the anterior cruciate ligament, the posterior cruciate ligament, the medial collateral ligament, and the lateral collateral ligament.

The graft block may be a unitary or multi-piece construction comprising any suitable biocompatible materials. Exemplary materials include metals, polymers, and/or other suitable materials and combinations thereof. For example, the graft block may comprise metals including stainless steels, titanium, titanium alloys, cobalt-chromium steels, nickel-titanium alloys, and/or others. The graft block may comprise nonresorbable polymers including polyolefins, polyesters, polyimides, polyamides, polyacrylates, poly(ketones), fluropolymers, siloxane based polymers, and/or others. The graft block may comprise resorbable polymers including polyesters (e.g. lactide and glycolide), polyanhydrides, poly(aminoacid) polymers (e.g. tyrosine based polymers), and/or others. The graft block may comprise other materials including nonresorbable and resorbable ceramics (e.g. hydroxyapitite, calcium sulfate) or biocompatible glasses.

The graft block includes means for attaching the graft to the block. The means for attaching the graft may include an aperture or channel formed in the graft block for receiving a portion of the graft or an additional intermediate connector. The aperture or channel may include a shielded portion with material overlying the aperture or channel to more fully retain and protect the graft and/or intermediate connector from abrasion with the bone tunnel wall. An intermediate connector can, for example, connect to a portion of the graft block and to a portion of the graft by being looped around or through the graft block or by having the graft block molded to the intermediate connector.

The graft and/or intermediate connector may connect to the graft block distally of the fixation means for fixing the graft block within the bone tunnel such that tensile forces on the graft result in compressive forces on the portion of the graft block between the graft and/or intermediate connector and the fixation means. This arrangement eliminates tensile forces on the graft block and prevents tensile breakage of the graft block from being a weak link in the system. In particular, this is helpful where the graft block is made of materials that perform better in compression rather than in tension; e.g. certain ceramics and degradable lactide and/or glycolide based polymers. The present investigators have found that in particular, polylactic acid is stronger, and its strength degrades in a more favorable manner, in vivo when loaded in compression rather than in tension. The intermediate connector may form a loop around a portion of the graft block, for example by being looped through the aperture or channel at the distal end of the graft block and extending beyond the proximal end of the graft block to receive the graft.

The intermediate connector may be flexible to allow it to compress and conform to the graft, graft block, and tunnel so that it can accommodate the smallest possible close fitting tunnel. Likewise, a flexible intermediate connector will distribute the stresses on the graft and graft block for a strong connection. A flexible intermediate connector may be in the form of a flexible member interposed between the graft block and the graft by being, for example, looped through an aperture or channel, having the graft block molded around the intermediate connector, or otherwise. For example, a flexible material may be looped through an aperture and extend beyond the graft block to form a flexible loop for receiving the graft. The intermediate connector may be both flexible and arranged to impart compressive forces on the graft block as described above. A flexible intermediate connector may comprise one or more continuous or closed loops of flexible material or it may comprise a strand of flexible material looped multiple times through or around a portion of the graft block. It may be formed by tying, bonding, otherwise joining, or forming as a single piece. The flexible material may comprise a single piece or a plurality of pieces, such as filaments, that are parallel, twisted, braided, woven, knitted, bonded or otherwise assembled into a cord, tape, fabric, or film.

The intermediate connector may comprise metals, resorbable polymers, non-resorbable polymers, and/or other biocompatible materials. For example, the intermediate connector may comprise non-resorbable materials such as stainless steel, titanium, titanium alloys, cobalt-chrome alloys, polyethylene, polyester, polylactic acid, polytetrafluroethylene, and/or silicone polymers. For example, the intermediate connector may comprise high strength polyethylene fiber. The intermediate connector may also comprise resorbable materials such as polylactic acid, polyglycolic acid, caprolactone, and/or polyamino acid polymers.

The graft block may also include means for passing the graft block longitudinally along the bone tunnel. The means for passing may include means for pushing and or pulling the graft block along the bone tunnel. For example, the graft block may be pushed with a rigid shaft engageable with the graft block. The graft block may be pulled with a rigid or flexible member engageable with the graft block. For example the graft block may include an aperture receiving a passing suture that is pulled from the opposite end of the bone tunnel. The graft block may also include means for aligning the graft block in a predetermined orientation within the bone tunnel, for example, in order to align with a transverse aperture to receive a transverse member to fix the graft block at a desired longitudinal position in the bone tunnel. One example of a means for aligning the graft block includes a keyway formed in the graft block for engaging a rotationally rigid member in a known rotational relationship such as a rigid shaft shaped to fit a slot to maintain the graft block in known rotational alignment with the shaft. Another exemplary means for aligning the graft block includes a projection extending radially from the graft block to engage a corresponding slot previously formed in the wall of the bone tunnel at a known circumferential position.

The means for fixing the graft block within the bone tunnel may include an aperture through the graft block or a surface formed on the graft block and a transverse member engageable with the aperture or surface and the wall of the bone tunnel. For example, the graft block may contain a transverse aperture for receiving a transverse pin extending through the aperture and into the bone on either side of the graft block. Alternatively, the graft block may contain a surface for abutting the transverse pin. The transverse member may be any suitable member for fixing the graft block including a pin, screw, bolt, staple and or other suitable member. It may be smooth or it may have means to help retain it in its position such as ribs, teeth, barbs, threads, and/or an expanding anchor arrangement or other suitable means. It may be inserted by pressing, impacting, rotating, or by other suitable means. For example, the transverse member can be a pin having a smooth first end and a second threaded end; the smooth end being received in the aperture of the graft block and the threads engaging the bone adjacent the bone tunnel. Furthermore, the transverse member may be a unitary construction or a multiple piece construction. For example, the transverse member may comprise a multiple piece cross-pin having a distal portion, a proximal cylindrical portion aligned longitudinally with the distal portion, and a junction between the distal and proximal portions. The junction may be any suitable junction to permit rotation of the proximal portion relative to the distal portion such that the proximal portion can be turned to move the distal portion axially without turning the distal portion. For example, the proximal portion can be threaded and the distal portion can be smooth. Such a cross-pin can be used with a graft block or with a graft alone. One advantage of such a two piece cross-pin is that the lack of rotation of the distal end reduces the likelihood of the distal end being entangled in the graft and/or suture. Another advantage of such a two-piece cross-pin is that the distal end can be made non-cylindrical to fit a non-cylindrical graft block aperture such as may be desirable with small bone tunnels where the graft block size is limited and would admit only a small cylindrical cross-pin. By making the pin non-cylindrical, the pin strength can be increased without the need to increase the graft block aperture diameter.

The transverse member may include means for engaging a member such as a pin, wire, suture, handle, or other suitable member to aid in guiding the transverse member into engagement with the graft block.

The graft retaining system is installed using a set of instruments for forming a graft bone tunnel and a transverse bone hole intersecting the bone tunnel. For example, the instruments may be used to form aligned tibial and femoral bone tunnels and a transverse bone hole intersecting at least the femoral bone tunnel. As an alternate example, the femoral tunnel may be drilled arthroscopically through a medial portal in the knee joint. The bone tunnel may be formed with a bone tunnel drill bit including depth markings for indicating the depth of the bone tunnel. The bone tunnel drill bit may be provided in an assortment of diameters so that the bone tunnel may be matched to the graft diameter.

The instruments may further include a transverse drill guide for guiding a transverse drill bit to form the transverse hole intersecting the bone tunnel. The drill guide may include a body for mounting modular removable guide rods and drill sleeves perpendicular to one another. The guide rods may be provided in an assortment of diameters to match the tunnel drill bit diameters. Each guide rod may include depth markings to measure the insertion depth of the guide rod into the bone tunnel. The measured insertion depth may then be compared to the tunnel depth measured with the tunnel drill bit to verify that the guide rod is fully seated. The guide rod may further include a transverse through bore to receive a transverse drill bit to permit the rod to remain fully seated in the bone tunnel while the transverse bone hole is drilled across the tunnel. The transverse through bore may simulate the position of a transverse aperture in the graft block. Furthermore, the transverse through bore may act as a depth stop to control the depth of the transverse bone hole. The guide rod may include a first longitudinal cannula for guiding a suture passing pin into the bone beyond the bone tunnel. The guide rod may further include a second longitudinal cannula opening radially outwardly to receive a notch cutter for cutting a rotational reference notch. The rotational reference notch may be referenced by a graft block having a radial projection to position the graft block in a predetermined radial alignment relative to the guide rod. For example, the second longitudinal cannula may be positioned so that it opens radially outwardly in a direction perpendicular to the longitudinal axis of the drill sleeve. A graft block may have a radial projection oriented perpendicular to an axis of a transverse aperture through the graft block. Thus, the graft block will be positioned with the aperture aligned with the drill sleeve when the radial projection is engaged with the rotational reference notch. The guide rods may include additional cannulae for receiving the notch cutter at different circumferential positions. For example, two such cannulae may be provided opposite one another so that rotational reference notches may be formed facing the same direction on both right and left portions of the patients body.

The drill sleeve may have an end that is shaped to engage the bone at a desired entry point for the transverse bone hole. The drill sleeve may include a window for viewing instruments and implants passed through the sleeve. A depth mark may be inscribed on the drill sleeve adjacent the window for determining the depth of implants and instruments in the sleeve.

The transverse drill bit fits closely within the drill sleeve so that the transverse drill bit is guided toward the guide rod positioned within the bone tunnel. The transverse drill bit may be stepped from a smaller diameter to a larger diameter to correspond to a stepped configuration of the transverse member. Furthermore, the transition from the smaller to the larger diameter may provide a shoulder engageable with the guide rod to stop the transverse drill bit from further insertion. The transverse drill bit may include depth markings that can be read adjacent a portion of the drill sleeve to indicate the distance from the shoulder to the end of the drill sleeve adjacent the desired entry point for the transverse bone hole. This measurement may be used to select a transverse member having a length that best fills the distance from the graft block to the desired entry point for the transverse bone hole.

A locator rod may be provided to help hold the drill sleeve in position on the bone and/or to maintain the location of the transverse bone hole when the other instruments are removed from the bone. The locator rod may include an end that is configured to press fit and/or thread into the transverse bone hole. The locator rod may include depth markings that can be read adjacent a portion of the drill sleeve to indicate that the locator rod is engaged with the bone beyond the distal end of the drill sleeve by a predetermined amount. The locator rod may be cannulated to receive an arthroscope for verifying the alignment of the graft block with the transverse bone hole.

A transverse bone hole access cannula may be provided to maintain the location of the transverse bone hole when the other instruments are removed from the bone. The transverse bone hole access cannula may include an end engageable with the transverse bone hole and a longitudinal bore for receiving instruments and the transverse member. The transverse bone hole access cannula may have an expandable end that is expandable from a first dimension engageable with the transverse bone hole to a second dimension sufficiently large to allow the transverse member to pass through the cannula.

A transverse member alignment instrument may be provided to help align the graft block with the transverse bone hole. The transverse member alignment instrument may have an external distal geometry similar to the external distal geometry of the transverse member. The transverse member alignment instrument may be insertable into the transverse bone hole to engage the graft block and align the graft block. The transverse member alignment instrument may further include an axial through bore to permit a suture to be passed through the graft block to be used to guide the transverse member into engagement with the graft block.

A driver for driving the transverse member may include depth markings that can be read adjacent a portion of the drill sleeve to indicate that the transverse member has been driven to a desired depth.

The method of using the instruments may include using an arthroscope directed through the drill sleeve to verify the alignment of the graft block with the transverse bone hole. The method may further include using a suture to guide the transverse member into engagement with the graft block.

FIGS. 1 and 2 illustrate an exemplary graft fixation system in use to replace the anterior cruciate ligament of a human knee. The fixation system 10 comprises a graft block 12, a cross-pin 14 and an intermediate connector in the form of a retaining loop 16. The graft block 12 comprises a body 20 having a proximal end 24 and a distal end 26. The terms “proximal” and “distal” are intended to refer to the orientation of the graft block 12 and the cross-pin 14 within their respective bone tunnels, the proximal end being closer to the tunnel entrance and the distal end being farther away. The body 20 is a generally rectilinear member having a pair of opposed and parallel planar faces 28 and 30 and a pair of opposed and parallel side faces 32 and 34. The planar side faces 28 and 30 may be used to provide relief areas for passing a suture 65 in the bone tunnel 60. When used in this way, the side faces 28 and 30 need not extend the full length of the body 20 as shown, but may alternatively extend only from the distal end to the smaller aperture 42. Alternatively, instead of opposed planar surfaces, relief for the suture 65 may be provided by a groove or trough extending distally from the smaller aperture 42 on each side of the graft block 12. A large aperture 40 extends transversely through the body 20 between faces 28 and 30. A chamfer 41 extends radially outwardly from the large aperture 40 and provides a tapering transition from the faces 28 and 30 to the large aperture 40. A smaller aperture 42 extends parallel to aperture 40 distally thereof. The body 20 is also provided with a pair of parallel longitudinal channels 50 (one side being shown in hidden line in FIG. 2) extending between the proximal 24 and distal 26 ends to receive a portion of the retaining loop 16 and retain it on the graft block 12. The channels 50 are also covered by the sides 32 and 34 to further retain the loop 16 and protect it from abrasion from the bone tunnel. The loop 16, which may be made of a flexible material, has a distal end 56 lying along distal end 26 of the graft block 12 and a proximal end 58 extending below the proximal end 24 of the body 20 to receive a graft 59 to attach it to the graft block 12. In the illustrative embodiment, the loop 16 comprises multiple strands of a flexible material. Alternatively, the channels 50 may be made large enough to receive the graft 59 directly. In the illustrative embodiment, the loop 16 passes distally over the large aperture 40 and connects the graft 59 proximally of the large aperture such that the portion of the graft block 12 between the loop 16 and the large aperture 40 is placed in compression when the graft 59 is placed in tension.

The side surfaces 32 and 34 may be cylindrical in part. The illustrative graft block 12 may be constructed by milling opposing flat faces 28, 30 on a cylindrical body, molding, sintering, or forming by other suitable methods. The diameter of the graft block body 20 is preferably slightly less than the diameter of the bone tunnel 60 to enable the body 20 to rotate about its axis to facilitate engagement with a cross-pin 14 while maintaining its longitudinal orientation within the tunnel.

The transverse member of this illustrative embodiment comprises a cross-pin 14 having a distal cylindrical section 100, a proximal cylindrical section 102, a tapered transition section 104 between the two cylindrical sections, and a tapered distal end 106 terminating in a pointed distal tip 108. The proximal end 110 of pin 14 is provided with a torque transmitting driver engagement portion such as a recessed, hexagonal drive recess 112. The proximal cylindrical section 102 may be provided with a retention means as previously mentioned. The illustrative embodiment of FIG. 1 includes cancellous screw threads 113 to enable the pin 14 to be advanced into or withdrawn from the femur along its longitudinal axis as it is rotated and to hold its position once it is placed. Alternatively, the cross-pin 14 may have a junction 115 between the proximal 102 and distal 100 sections to permit rotation of the proximal section 102 relative to the distal section 100 such that the proximal section 102 can be turned to drive the distal section 100 while the distal section 100 does not turn.

The diameter of the distal section 100 is approximately equal to the diameter of the large aperture 40 of the graft block 12. The tapered distal end 106 facilitates engagement of the pin with the aperture 40. If the graft block 20 is situated in the tunnel with the aperture axis partially out of alignment with the pin axis, the tapered distal end 106 and the chamfer 41 will engage one another and cause the graft block 12 to rotate about its axis to align the aperture 40 with the pin 14.

FIG. 3 illustrates an alternative embodiment of the graft block 12 of FIG. 1 having a longitudinally extending radial projection 200. The projection 200 engages a slot or notch 202 previously formed in the wall of the bone tunnel at a known circumferential position such that the projection 200 is received in the slot 202 as the graft block 12 is inserted into the bone tunnel to align the aperture 40 with the transverse hole 64.

FIG. 4 illustrates an alternative embodiment of the graft block 12 of FIG. 1 having an optional keyway for engaging a rotationally rigid shaft shaped to fit the keyway. The keyway may have one or more openings. In the illustrative embodiment, the keyway comprises a pair of notches 300 that are adapted to receive a forked inserter (not shown) which has a gap between the forks to accommodate the graft 59 and/or intermediate connector. The engagement of the shaft and keyway maintains the graft block 12 in known rotational alignment with the shaft so that the shaft can be positioned to properly align the graft block 12 with the transverse hole 64. The illustrative embodiment of FIG. 4 also depicts an optional longitudinally elongated aperture 340. Such an elongated aperture 340 may be useful, for example, in a small diameter bone tunnel to facilitate a transverse member having a corresponding non-cylindrical cross-section to increase the strength of the transverse member without requiring a larger graft block diameter. For example, the cross-pin 14 of FIG. 1 may be made with a non-cylindrical distal section 100. This may be advantageously combined with the above described alternative cross-pin having a rotating junction between the proximal 102 and distal 100 sections. In this way, the proximal end 102 may be rotated while the non-cylindrical distal section progresses without rotation. Alternatively, a non-cylindrical cross-pin may be impacted or pressed into position. The non-cylindrical aperture of FIG. 4 may also be used with a transverse member having a round cross-section to permit the transverse member to engage the graft block even when there is some longitudinal misalignment of the graft block 12 with the transverse hole 64. The transverse member may pass through the aperture 340 proximal to the distal end 342 of the aperture. If so, when the graft 59 is tensioned, the graft block 12 will be pulled proximally until the distal end 342 engages the transverse member. The aperture 340 is chamfered 41 to also permit some rotational misalignment as described above.

FIG. 5 illustrates an alternative embodiment of the cross-pin 14 of FIG. 1 having an optional longitudinal cannulation 390 to permit the cross-pin 14 to follow a guide wire 392 if desired.

FIGS. 6 and 7 illustrate an alternative embodiment of the graft block of FIG. 1 having a multi-piece construction. A graft block 400 comprises a cap 402, a core 404, and an intermediate connecting member 406 in the form of a loop. The core 404 includes a rectilinear body having a proximal end 408, a distal end 410, a pair of opposed parallel faces 412 and 414, and a pair of opposed parallel sides 416 and 418. Large 420 and small 422 transverse apertures extend through the body between the faces 412 and 414. The large 420 aperture is proximal of the small aperture 422 and includes a chamfer 423. A pair of projecting side walls 424 and 426 defines a U-shaped channel 428 along the exterior of the core 404 around the distal end and down the parallel sides 416 and 418. The intermediate connecting member 406 comprises a closed elongated loop having a proximal portion 430, a distal portion 432, and sides 434 and 436. The cap 402 includes a hollow rectilinear body having an open proximal end 450, a closed distal end 452, opposite parallel faces 454 and 456, and opposite parallel sides 458 and 460. Large 462 and small 464 transverse apertures extend through both faces 454 and 456. Chamfers 466 and 467 lead from each face 454 and 456 to the large 462 and small 464 apertures. The graft block 400 is assembled by placing the intermediate connector 406 on the core 404 within the U-shaped channel 428 with the distal portion 432 resting on the distal end 410 of the core 404 and the proximal portion 430 extending below the core. The core/connector assembly is inserted through the open proximal end 450 of the cap 402 until the distal end 410 of the core 404 is adjacent the distal end 452 of the cap 402 and the large 420 and small 422 core apertures align with the large 462 and small 464 cap apertures. The assembly may be secured by press fit, snap fit, adhesives, welding, solvent bonding, pinning, screwing, and/or other suitable means. Alternatively, the cap 402 can be molded over the core 404 and intermediate connector 406 or the cap 402 and core 404 can be molded as a single piece around the intermediate connector 406. When fully assembled, the cap covers the distal end 432 and sides 434 and 436 of the intermediate connector 406 such that it is securely retained and protected.

FIG. 8 depicts an alternative cap 402 having a cylindrical body without the faces 454 and 456 of FIG. 6. A pair of channels 500 lead from each end of the small aperture 464 toward the distal end 452 of the cap 402. The channels 500 receive the passing suture 65 to provide clearance between the cap 402 and bone tunnel.

FIGS. 9-20 depict an illustrative set of surgical instruments and their use in an illustrative surgical method to install the graft retaining system of FIGS. 1-8. Referring to FIGS. 9-14, the set of surgical instruments includes a tunnel drill bit 550, a transverse drill guide base 600, a tunnel guide rod 650, a drill bushing or sleeve 700, a transverse drill bit 750, a locator rod 800, a notch cutter 850, a suture passing pin 900, and a driver 950.

The tunnel drill bit 550 includes a cylindrical body 552 having a proximal end 554, a distal end 556, and an axis 558 extending therebetween. Cutting flutes 560 are formed adjacent the distal end 556 to cut into the bone to form tibial and femoral bone tunnels 504, 510 (FIG. 15). Depth markings 562 on the body 552 can be viewed intraoperatively within the joint to determine the depth of the femoral bone tunnel 510. A driver engagement 564 is formed near the proximal end 554 to permit the tunnel drill bit 550 to be easily connected to a powered drill or other driver. A plurality of tunnel drill bits 550 having different diameters is provided so that the bone tunnels 504, 510 may be matched to the graft 59 (FIG. 1) size for a close fit between the graft 59 and tunnels 504, 510.

The base 600 includes an “L”-shaped body 602 providing a rigid mounting for the instruments. The base 600 has a rod interface 604 at one end and a sleeve interface 606 at an opposite end. The rod interface 604 includes a lug receiving slot 608 and a locking bolt 610. A hole 611 in the rod interface 604 communicates with the lug receiving slot 608 and is threaded to receive the locking bolt 610 such that an end 612 of the locking bolt is positionable in the lug receiving slot 608. The sleeve interface 606 includes an outer surface 613, a longitudinal through bore 614, and a longitudinal through slot 616 along one side of the bore 614 communicating from the bore 614 to the outer surface 613. The slot 616 is slightly narrower than the bore 614 diameter such that the bore 614 and slot 616 form a longitudinal keyhole aperture open on one side.

The tunnel guide rod 650 references the bone tunnels 504, 510 to help align the base 600 and other instruments. The tunnel guide rod 650 includes a cylindrical rod body 652 having a cylindrical outer wall, a proximal end 654, a distal end 656, and an axis 658 extending therebetween. The rod body 652 includes a first longitudinal cannula 660 extending along the axis 658 from the proximal end 654 to the distal end 656. A second longitudinal cannula 662 is radially offset from the first cannula 660 and extends parallel to the first cannula 660 from the proximal end 654 to the distal end 656 for receiving the notch cutter 850. The second cannula 662 is radially offset such that a chord 664 of the cannula 662 intersects the outer wall of the rod body 652. This intersection creates an outwardly opening slot 665. The tunnel guide rod 650 includes a transverse through bore 668 spaced a predetermined distance from the distal end 656. The outwardly opening slot 665 is oriented at a predetermined circumferential position relative to the transverse bore 668 corresponding to the position of the radial projection 200 of the graft block 12 relative to the aperture 40 (FIG. 3). In the illustrative embodiments, the slot 665 and projection 200 are oriented perpendicular to the transverse bore 668 and aperture 40. Depth markings 670 are formed on the rod body 652. The depth markings 670 correspond to the depth markings 562 on the tunnel drill bit 550. A transverse attachment lug 672 is positioned near the proximal end 654. The attachment lug 672 is receivable by the lug receiving slot 608 of the rod interface 604 on the drill guide base 600. With the attachment lug 672 seated in the lug receiving slot, the locking bolt 610 can be tightened against the attachment lug 672 to attach the tunnel guide rod 650 to the drill guide base 600. A plurality of positioning rods 650 having different diameters is provided to match the tunnel drill bit 550 diameters.

The drill sleeve 700 includes a hollow, cylindrical barrel 702 having a cylindrical outer wall, a proximal end 704, a distal end 706 and a longitudinal axis 708 therebetween. The barrel 702 is open both proximally and distally to provide an elongated portal 703 from the proximal end 704 to the distal end 706. Teeth 710 are formed at the distal end 706, for example by cutting scallops across the distal end 706, to facilitate the distal end 706 gripping a bone surface. A window 712 for viewing implants and instruments passed through the portal 703 is formed in the side of the barrel 702 communicating from the outer wall to the portal 703. A depth marking 713 is formed on the outer wall of the drill sleeve 700 adjacent the window 712 to provide a depth reference for instruments and implants passed through the portal 703. An enlarged ring 714 is formed near the proximal end 704 to provide an enlarged gripping surface. The ring 714 has an outer diameter larger than the outer diameter of the barrel 702. The ring 714 includes planar proximal 716 and distal 718 surfaces. The proximal surface 716 may also be used to provide a depth reference for instruments and implants passed through the portal 703. A locking bolt 720 projects radially from the outer wall of the barrel 702 and threadably receives a locking nut 722. The barrel 702 is sized to slide into the sleeve interface 606 through bore 614 where it is constrained to axial translation along the bore 614. The barrel 702 is larger than the slot 616 so that the barrel cannot fit radially through the slot 616. The slot 616 receives the bolt 720 in sliding relationship. The drill sleeve 700 can be positioned within the bore 614 at a desired location and then locked in place by tightening the locking nut 722 against the outer surface 613 of the sleeve interface 606.

With the positioning rod 650 assembled to the rod interface 604 and the drill sleeve 700 assembled to the sleeve interface 606, the barrel 702 portal 703 is aligned with the transverse through bore 668 in the positioning rod 650. Thus, instruments and implants passed through the drill sleeve 700 may be directed toward and/or through the transverse bore 668.

The transverse drill bit 750 includes a proximal end 752, a distal end 754, and a longitudinal axis 756 therebetween. The transverse drill bit 750 is guided by the drill sleeve 700 to form the transverse bone hole 64 (FIG. 16) intersecting the bone tunnel 510. A first drilling portion 758 is formed adjacent the distal end 754. The first drilling portion 758 corresponds to a predetermined hole size for receiving the distal cylindrical section 100 of the cross-pin 14. A second drilling portion 760 is formed between the first drilling portion 758 and the proximal end 752. The second drilling portion 760 has a larger diameter than the first drilling portion 758 that corresponds to a predetermined hole size for receiving the proximal cylindrical section 102 of the cross-pin 14. A tapered shoulder 762 transitions between the first 758 and second 760 drilling portions. The drill bit 750 includes a smooth cylindrical bearing portion 764 between the second drilling portion 760 and the proximal end 752. The bearing portion 764 has a diameter sized to fit the internal diameter of the drill sleeve 700 portal 703 in smooth rotational and axial sliding engagement. The drill bit 750 includes a plurality of depth markings 766. With the drill bit 750 positioned within the drill sleeve 700, the depth markings 766 may be read adjacent the proximal surface 716 of the ring 714. The depth markings 766 are calibrated to indicate the distance from the drill bit shoulder 762 to the distal end 706 of the drill sleeve 700. A driver engagement 772 formed at the proximal end 752 allows quick coupling to a driver for turning the drill bit 750.

The locator rod 800 includes a cylindrical body 801, a proximal end 802, a distal end 804, and an axis 806 extending therebetween. The cylindrical body 801 is a close sliding fit within the drill sleeve 700 but it will pass radially through the slot 616 of the sleeve interface 606. The locator rod 800 includes threads 808 formed adjacent the distal end 804. The threads 808 are sized to engage the transverse bone hole 64 formed by the second drilling portion 760 of the transverse drill bit 750. The locator rod 800 includes proximal 810 and distal 812 depth markings. The proximal depth marking 810 aligns with the proximal surface 716 of the drill sleeve 700 ring 714 and the distal depth marking 812 aligns with the depth marking 713 adjacent the drill sleeve 700 window 712 when the locator rod 800 is fully engaged in the transverse bone hole 64 as measured relative to the distal end 706 of the drill sleeve 700. The locator rod 800 includes a driver engagement 814 formed at the proximal end 802 that allows quick coupling to a driver or handle for turning the locator rod 800 into the bone. The illustrative locator rod 800 includes an optional axial cannula 816 for receiving an arthroscope. This cannula 816 permits examination of the transverse bone hole 64 and/or viewing of the orientation of the graft block 12 relative to the transverse bone hole 64 while the locator rod 800 is engaging the transverse bone hole 64.

The notch cutter 850 includes a proximal end 852, a distal end 854, and a longitudinal axis 856 therebetween. A cylindrical shaft 858 extends from the distal end 854 toward the proximal end 852. A cutter tooth 860 in the general form of a rectangular prism projects radially from the cutter shaft 858 near the distal end 854. The cutter tooth 860 has a sharpened distal edge 864. The cylindrical shaft 858 is sized to slide within the second cannula 662 in the tunnel guide rod 650 with the cutter tooth 860 projecting radially outwardly through the outwardly opening slot 665. A handle 868 is formed adjacent the proximal end 852 of the notch cutter 850.

The suture passing pin 900 includes a cylindrical body 901 having a proximal end 902, a distal end 904, and a longitudinal axis 906 extending therebetween. A sharpened tip 908 at the distal end facilitates driving the pin through bone to form a suture hole. An eyelet 910 formed at the proximal end 902 receives a suture to be pulled through the suture hole formed by the pin 900.

The driver 950 includes a proximal end 952, a distal end 954, and an axis 956 therebetween. A cylindrical shaft 958 extends from the distal end 954 toward the proximal end 952 and a handle 966. An engagement tip 960 is formed adjacent the distal end 954 and is shaped to engage the drive recess 112 of the cross-pin 14 (FIG. 1). The driver 950 includes proximal 962 and distal 964 depth markings. The proximal depth marking 962 aligns with the proximal surface 716 of the drill sleeve 700 ring 714 and the distal depth marking 964 aligns with the depth marking 713 adjacent the drill sleeve 700 window 712 when the driver 950 engages the cross-pin 14 and the cross-pin 14 is counter sunk to a desired level relative to the distal end 706 of the drill sleeve 700.

The use of the illustrative instruments of FIGS. 9-14 is shown in FIGS. 15-20. A suitable graft 59 is prepared and connected to the graft block 12. For example a semitendinosus or gracilis tendon is harvested and connected to the graft block 12 via the retaining loop 16. The graft block 12 is chosen to match the diameter of the graft 59. A bone tunnel drill bit 550 is chosen with a diameter that will form a tunnel that closely fits the graft 59/graft block 12 assembly. A bone tunnel 504 is drilled through the tibia 502 from a first end 506 to a second end 508. The tunnel drill bit 550 is advanced further to drill a tunnel 510 into the femur 512 from a first end 514 to a second end 516, in line with the tibial tunnel 504 as shown in FIG. 15. Alternatively, the femoral tunnel 510 can be drilled through a medial portal in the knee joint and need not necessarily align with the tibial tunnel 504. The depth of the femoral tunnel 510 from the first end 514 to the second end 516 is measured by reading the depth from the depth markings 562 on the tunnel drill bit 550 while it is fully seated against the second end 516 of the tunnel 510. The tunnel drill 550 bit is removed and the depth of the femoral bone tunnel 510 is marked 518 on the graft 59/graft block 12 assembly as measured from the distal end of the assembly. The mark 518 (FIG. 18) will serve as an indicator of when the graft block 12 is fully seated in the bone tunnel.

A tunnel guide rod 650 is selected having a diameter corresponding to a desired fit within the bone tunnels 504, 510. The tunnel guide rod 650 is assembled to the drill guide base 600 and then inserted through the tibial 504 and femoral 510 bone tunnels and seated against the second end 516 of the femoral bone tunnel 510 as shown in FIG. 16. Alternatively, if the femoral tunnel. 510 was formed through a medial portal, the femoral positioning rod 650 is inserted through the medial portal and into the femoral tunnel 510. The user can verify that the tunnel guide rod 650 is fully seated by referring to the depth marks 670. Seating is confirmed if the indicated femoral tunnel 510 depth corresponds to the depth measured during drilling. The drill sleeve 700 is inserted through the sleeve interface 606 and through a skin incision until the drill sleeve 700 teeth 710 grip the anterolateral femoral cortex 66. The drill sleeve 700 is then locked in place by tightening the locking nut 722.

The transverse drill bit 750 is inserted through the sleeve 700 portal 703 and activated to drill a transverse hole 64 from the anterolateral femoral cortex 66 to intersect the femoral bone tunnel 510. The distal drilling portion 758 passes through the transverse bore 668 of the tunnel guide rod 650 and on into the femur on the opposite side of the femoral bone tunnel 510. The shoulder 762 will eventually seat against the femoral guide rod 650 at the transverse bore 668 and halt the progress of the drill bit 750. With the shoulder 762 seated, the distance from the shoulder 762 to the anterolateral femoral cortex 66 can be read by noting which depth marking 766 on the transverse drill bit 750 is adjacent the proximal surface 716 of the enlarged ring 714. This depth measurement is then used to select a cross-pin 14 having a proximal length that will allow it to seated against the graft block 12 and extend to a desired position near the anterolateral femoral cortex 66. It is advantageous for the transverse pin 14 to reach a position near the anterolateral femoral cortex 66, but not project from it.

If the graft block 12 of FIG. 3 is being used, the radial notch 202 is formed to receive the radial projection 200 of the graft block 12. The transverse drill bit 750 may be left in place to help hold the drill guide in position or it may be removed and replaced with the locator rod 800. The notch cutter 850 shaft 858 is inserted into the second cannula 662 of the tunnel guide rod 650 with the cutter tooth 860 projecting through the longitudinal slot 665. The notch cutter 850 is pushed distally so that the cutting edge 864 of the cutter tooth 860 engages the bone and forms the notch 202 in the walls of the bone tunnels 504, 510. The notch cutter 850 is removed. If the transverse drill bit 750 was not removed before forming the notch 202, it is now removed from the drill sleeve 700 and the locator rod 800 is inserted through the drill sleeve 700 and threaded into the transverse hole 64 until the threads 808 are fully engaged in the bone as shown in FIG. 17.

The suture passing pin 900 is inserted into the first cannula 660 and is driven until it is embedded in the femur 512 beyond the second end 516 of the femoral bone tunnel 510. The drill sleeve 700 locking nut 722 is loosened and the drill sleeve 700 is slid out of the axial bore 614 and off of the locator rod 800. The femoral guide rod 650 and drill guide base 600 are removed by displacing the base 600 proximally and sliding the sleeve interface 606 slot 616 over the locator rod 800 and the femoral guide rod 650 out of the bone tunnels 504, 510. The locator rod 800 maintains access through the surrounding soft tissue to the transverse bone hole 64 and allows easy subsequent repositioning of the drill sleeve 700 as shown in FIG. 18.

The graft block 12 suture 65 is threaded through the eye 910 of the suture passing pin 900 and the suture passing pin 900 is advanced to form the suture tunnel 68 through the femur out through the anterolateral femoral cortex 66, and adjacent to or through the quadriceps muscle. Pulling the suture passing pin 900 through the suture tunnel 68 pulls the suture 65 through the tibia 502 and the femur 512. If present, the radial projection 200 is aligned with the tibial tunnel 504 notch 202 cut in the tunnel 504 sidewall. The suture 65 is pulled to advance the graft block 12 into the joint space 520. The graft block 12 is rotationally aligned so that its aperture 40 is aligned with the transverse bone hole 64. If present, the radial projection 200 is aligned with the notch 202 in the femoral bone tunnel 510. The suture 65 is pulled to seat the graft block 12 in the femoral bone tunnel 510. Optionally, seating can be checked by viewing the mark 518 relative to the femoral bone tunnel 510 first end 514. Seating is verified if the mark 518 is adjacent the first end 514. Also optionally, an arthroscope can be directed down the locator rod 800 cannula 816 to verify the alignment of the graft block 12 relative to the transverse bone hole 64. The drill sleeve 700 is now replaced over the locator rod 800 until its teeth 710 bite into the anterolateral femoral cortex 66 as shown in FIG. 19. The locator rod 800 is removed by unscrewing it from the transverse bone hole 64. Optionally, an arthroscope may be inserted into the drill sleeve 700 to verify the alignment of the graft block 12.

The cross-pin 14 is advanced through the drill sleeve 700 (FIG. 20) and into the transverse hole 64 until the first cylindrical portion 100 of the cross-pin 14 passes through the large aperture 40 of the graft block and into the femur on the opposite side thus securing the graft 59/graft block 12 assembly in the bone tunnel 510. The graft block 12 aperture 40 only needs to be in general alignment with the transverse hole 64 prior to passing the graft block 12 into the bone tunnel. Once the graft block 12 is seated in the bone tunnel 510, the cross-pin 14 is advanced to secure the graft block 12 in the tunnel 510. Because of the chamfered 41 entrance of the aperture 40 and the taper 106 on the pin 14, the pin 14 can engage the graft block 12 such that even if there is some misalignment, the graft block 12 will rotate into alignment with the cross-pin 14. The cross-pin 14 may be advanced until the transition section 104 seats against the chamfered entrance 41 of the aperture 40. Alternatively, the cross-pin 14 may be advanced until the proximal depth markings 962, 964 on the driver align with the proximal surface 716 of the drill sleeve 700 and window 712 depth marking 713 respectively. The depth markings are arranged so that when they are aligned, the proximal end 110 of the cross-pin 14 is countersunk a desired amount beyond the distal end 706 of the drill sleeve 700.

FIG. 21 shows an alternative illustrative depth gauging arrangement for drilling the transverse bone hole 64. In this embodiment, the transverse drill bit 750 includes a drill stop mark 970 distal to the plurality of depth markings 766. The drill sleeve 700 includes an elongated proximal window 972 extending through the side of the drill sleeve barrel 702 to communicate with the drill sleeve portal 703. This window 972 permits visualization of the drill stop mark 970 on the transverse drill bit 750. The sleeve interface 606 of the “L”-shaped body 602 includes a notch 974 adjacent the elongated through bore 614. Drill stop lines 976 are formed on the sleeve interface 606 adjacent the notch 974. In use, the tunnel guide rod 650 is inserted into the femoral bone tunnel 510 and the distal end 706 of the drill sleeve 700 is positioned against the anterolateral femoral cortex 66. The notch 974 in the sleeve interface 606 permits visualization of the drill stop mark 970 even if the ring 714 of the drill sleeve 700 is seated against the sleeve interface 606 as may occur in the case of a small bone. The transverse drill bit 750 is placed in the drill sleeve 700 and drilled into the femur until the drill stop mark 970 aligns with the drill stop lines 976 within the notch 974. The drill stop lines 976 are in a fixed position on the sleeve interface 606 which is in a known fixed position relative to the tunnel guide rod 650. Thus, aligning the drill stop mark 970 with the drill stop lines 976 positions the transverse drill at a predetermined depth relative to the tunnel guide rod 650. The use of the drill stop mark 970 provides an alternative to the transverse drill bit 750 shoulder 762 bottoming on the tunnel guide rod 650 to establish proper transverse bone hole 64 depth. The drill stop mark 970 is positioned so that the shoulder 762 stops just short of bottoming on the femoral positioning rod 650. The shoulder 762 then acts as a secondary stop if the transverse drill 750 is inadvertently advanced past the drill stop mark 970. The distance from the shoulder 762 to the anterolateral femoral cortex 66 is then read by noting which depth marking 766 on the transverse drill bit 750 is adjacent the proximal surface 716 of the ring 714 as before. This distance measurement is a guide to selecting the appropriate length transverse pin 14.

FIG. 22 shows another alternative illustrative depth gauging arrangement for drilling the transverse bone hole 64. In this embodiment, a depth stop 980 is mounted on the sleeve interface 606 and projects proximally. The depth stop 980 includes a stop body 982 having a “U”-shaped opening 983 for receiving the transverse drill bit 750. A support rod 984 connects the stop body 982 to the sleeve interface 606. One end of the support rod 984 is fixed to the stop body 982 and the other end is releasably received by a socket 986 in the sleeve interface 606 below the longitudinal through bore 614. The enlarged ring 714 of the drill sleeve 700 includes a through hole 988 below the elongated portal 703 for the support rod 984 to pass through. Graduations 990 are formed at intervals along the support rod 984. The transverse drill bit 750, includes a stop collar 992 near its proximal end. In use, the drill sleeve 700 is engaged with the sleeve interface 606. The depth stop 980 is mounted by inserting the support rod 984 through the hole 988 in the ring 714 of the drill sleeve 700 and into engagement with the socket 986 of the sleeve interface 606. The tunnel guide rod 650 is inserted into the femoral bone tunnel 510 and the distal end 706 of the drill sleeve 700 is positioned against the anterolateral femoral cortex 66. The transverse drill bit 750 is placed in the drill sleeve 700 and drilled into the femur until the stop collar 992 abuts the depth stop 980. The depth stop 980 is connected to a fixed position on the sleeve interface 606 which is in a known fixed position relative to the tunnel guide rod 650. Thus, using the depth stop 980 positions the transverse drill at a predetermined depth relative to the tunnel guide rod 650. The use of the depth stop 980 provides an alternative to the transverse drill bit 750 shoulder 762 bottoming on the tunnel guide rod 650 to establish proper transverse bone hole 64 depth. The distance from the shoulder 762 to the anterolateral femoral cortex 66 is then read by noting which graduation 990 on the support rod 984 is adjacent the proximal surface 716 of the ring 714. This distance measurement is a guide to selecting the appropriate length transverse pin 14.

FIGS. 23 and 24 depict an optional attachment mechanism for an intermediate connector such as retaining loop 16. The graft block 12 includes a groove 1600 formed along the distal end 26. The groove 1600 has a smooth convex bottom surface 1602 for supporting the retaining loop 16 and a pair of opposing side walls 1601, 1603 for containing the retaining loop 16. A pair of opposing holes 1604, 1606 are formed through the distal end 26 and open to the bottom surface of the groove 1600 at each end. Each hole 1604, 1606 includes an enlarged counter bore 1608, 1610 for receiving the end of an elongate member 1612 forming the retaining loop 16. The retaining loop 16 is attached to the graft block 12 by threading a first end 1613 of the elongate member 1612 through one of the holes 1604. The first end 1613 may be secured in the hole 1604 by knotting it, inserting a wedge, adhering it, or by other suitable means. In the illustrative embodiment, the first end 1613 is threaded through the hole 1604 so that it extends beyond the counter bore 1608. A first knot 1614 is tied in the first end of the elongate member 1612 and then pulled back so that the first knot 1614 lies within the counter bore 1608. The elongate member is then looped through the channels 50 one or more times to form the desired size of retaining loop 16. The second end of the elongate member 1612 is then threaded through the other hole 1606 through the distal end 26 of the graft block so that the second end extends beyond the counter bore 1610. A second knot is tied in the second end of the elongate member 1612 and then pulled back so that the second knot lies within the counter bore 1610. With the knots contained within the counter bores 1608, 1610, the retaining loop 16 may lie flat against the distal end 26 of the graft block 12 between the opposing walls 1601, 1603.

FIGS. 25-30 depict an alternative embodiment of a graft fixation system 1710 in use to replace the anterior cruciate ligament of a human knee. The fixation system 1710 comprises a graft block 1712, a cross-pin 14, and a pushing member 1716. The graft block 1712 comprises a body 1720 having a proximal end 1724 and a distal end 1726. A “saddle-like” trough 1730 is formed adjacent the distal end 1726 to receive the graft 59. The trough 1730 includes a smooth, convex support surface 1732 formed about an axis 1733 and being bounded at each end by opposing end walls 1734. The end walls 1734 may optionally include through holes for receiving a passing suture like the embodiment of FIG. 1. The end walls 1734 are spaced apart to provide a close fit to the graft 59 as it wraps over the support surface 1732 to contain the graft 59 on the graft block 1712. The support surface 1732 has a sufficiently large radius to support the graft without cutting into the graft 59 or otherwise unduly stressing the graft 59. The outer surface 1728 of the graft block 1712 is cylindrical to fit within the tibial 1760 and femoral 1762 bone tunnels and permit rotation of the graft block within the tunnels 1760, 1762. A semi-circular cutout 1736 is formed adjacent the proximal end 1724 to receive the cross-pin 14. In the illustrative embodiment, the cutout 1736 is formed parallel to the support surface axis 1733 through downwardly projecting extensions 1738 of the end walls 1734 and along the bottom 1740 of the support surface 1732. A pair of sockets 1742 is formed into the bottom 1740 of the support surface 1732 to engage the pushing member 1716. The sockets 1734 are spaced apart axially to position the pushing member between the strands of the graft 59 as they extend proximally away from the graft bock 1712.

The pushing member 1716 includes a flat, plate-like body 1750 having an engagement end 1752 and a grip end 1754. The engagement end includes two prongs 1756 projecting outwardly to engage the sockets 1742 in the graft block 1712. The prongs 1756 may be formed as permanent extensions of the body 1750, or they may be retractable. In the illustrative embodiment of FIG. 30, the prongs 1756 are rods fit into longitudinal channels 1755 formed in the body 1750. Actuator button 1757 is connected to the prongs 1756 and is movable in a slot 1758 to extend and retract the prongs 1756. An attachment lug 1759 extends from the side of the body 1750 adjacent the grip end 1754 to permit the pushing member 1716 to optionally be connected to the transverse drill guide base 600 for positive positioning of the graft 59/graft block 1712 assembly. With the two prongs 1756 engaged with the sockets 1742, the graft block 1712 may be pressed into the bone tunnels 1760, 1762 and aligned with the transverse hole 1764.

In use, the bone tunnels and transverse hole 1764 are generally prepared as described relative to FIGS. 15 and 16. The tibial tunnel 1760 is drilled to a diameter slightly larger than the graft 59 diameter. The femoral tunnel 1762 is also drilled to a diameter slightly larger than the graft 59 diameter and to a predetermined depth dictated by the desired length of graft to be placed into the femoral tunnel 1762. The transverse hole 1764 is formed to intersect the femoral tunnel 1762. A graft block 1712 is chosen to match the tunnel diameter, and the pushing member 1716 is engaged with the graft block with the prongs 1756 in the sockets 1742. The graft 59 is looped over the support surface 1732 and extended along the sides of the pushing member 1716. The graft 59/graft block 1712 assembly is then passed through the tibial 1760 and femoral 1762 tunnels by applying force to the pushing member 1716. The graft block 1712 then aligned with the transverse hole 1764.

Insertion and alignment of the graft 59/graft block 1712 assembly may be facilitated by first coupling the pushing member 1710 to the base 600. The attachment lug 1759 is inserted into lug receiving slot 608 of the base 600. Locking bolt 610 is tightened to clamp the lug 1759 in the slot 608. Thus assembled, the semi-circular cutout 1736 in the proximal end 1724 of the graft block 1712 is aligned with the sleeve interface bore 614 both longitudinally and rotationally. The base 600 can now be used as a handle to insert the graft 59/graft block 1712 assembly along the bone tunnels until the cutout 1736 is aligned with the transverse hole 1764. Alignment is confirmed when the locating rod 800 passes through the sleeve interface slot 616 and enters the sleeve interface bore 614.

Once the graft 59/graft block 1712 assembly is seated in the femoral tunnel 1762, the pushing member 1716 is withdrawn. Disengaging the pushing member 1716 from the graft block 1712 may be facilitated by first retracting the prongs 1756 by sliding the actuator button 1757 proximally. The cross pin 14 is then inserted into the transverse hole 1764 and advanced until it engages the semi-circular cutout 1736 and seats in the bone on the medial and lateral sides of the femoral tunnel 1762 as described relative to the previous embodiments.

The combination of the graft block 1712 and the cross pin 14 permits the use of a larger support surface 1732 to reduce stresses on the graft 59 and a smaller cross pin 14 to minimize the size of the transverse hole 1764 and ease insertion as compared to using a pin 14 alone.

FIG. 31 depicts an alternative exemplary configuration of the set of surgical instruments of FIGS. 10 and 11. The set of surgical instruments includes a transverse drill guide base 2100, a tunnel guide rod 2150, a drill bushing or sleeve 2200, a transverse drill bit 2250, and a transverse bone hole access cannula 2300.

The transverse drill guide base 2100 of FIG. 31 is similar to the “L”-shaped base 600 of FIG. 11. However, the base 2100 of FIG. 31 includes an alternative tunnel guide rod attachment mechanism including an antirotation notch 2102, a through bore 2104, and a female threaded knob 2106. The base 2100 further includes holes 2108 to reduce its weight. The drill sleeve interface 2110 includes a cylindrical through bore 2112 for receiving the drill sleeve 2200.

The tunnel guide rod 2150 includes a cylindrical rod body 2152, a longitudinal bore 2154, a transverse through bore 2156 near the distal end 2157, and depth markings 2158 similar to the tunnel guide rod 650 of FIG. 10. A collar 2160 having flats 2162 is positioned near the proximal end 2164. The proximal end includes threads 2166 to engage the threaded knob 2106. The tunnel guide rod 2150 is mounted on the transverse drill guide base 2100 by inserting the proximal end 2164 of the tunnel guide rod 2150 through the bore 2104 in the base 2100 and engaging the threads 2166 of the tunnel guide rod 2150 with the threads 2165 of knob 2106. As the tunnel guide rod 2150 seats on the base, the collar 2160 abuts the bottom of the antirotation notch 2102 to establish the proximal-distal position of the tunnel guide rod 2150 with the transverse bore 2156 level with the transverse bore 2112 of the drill sleeve interface 2110. The flats 2162 on the collar 2160 engage the sides of the antirotation notch 2102 to establish the rotational position of the tunnel guide rod 2150 such that the transverse bore 2156 is rotationally aligned with the bore 2112 of the drill sleeve interface 2110.

The drill sleeve 2200 includes a hollow, cylindrical barrel 2202 having a proximal end 2204, a distal end 2206 and a longitudinal axis therebetween. The barrel 2202 is open both proximally and distally to provide an elongated portal from the proximal end 2204 to the distal end 2206. The internal diameter of the drill sleeve 2200 is sized to receive the transverse drill bit 2250 in sliding relationship to guide it toward the transverse bore 2156 of the tunnel guide rod 2150. The external diameter of the drill sleeve 2200 is stepped (FIG. 32) having a larger diameter outer portion 2208 sized to press fit into the transverse bore 2112 of the drill sleeve interface 2110 and a smaller diameter outer portion 2210 sized to receive the transverse bone hole access cannula 2300 in sliding relationship. The drill sleeve 2200 may be permanently mounted to the drill sleeve interface 2110 or it may be removable for cleaning or to permit the use of different sizes of drill sleeves to accommodate different sizes of transverse drill bits 2250 and/or transverse bone hole access cannulae 2300. The interfaces between the drill sleeve 2200 and the drill sleeve interface 2110 and access cannula 2300 may also be non-cylindrical. The interface between the drill sleeve 2200 and the drill sleeve interface 2110 may also include a locking mechanism such as that shown in FIG. 11.

The transverse drill bit 2250 includes a proximal end 2252, a distal end 2254, and a longitudinal axis therebetween. The transverse drill bit 2250 is guided by the drill sleeve 2200 to form a transverse bone hole 1900 (FIG. 45) intersecting a bone tunnel 1902. As with the transverse drill bit 750 of FIG. 11, the transverse drill bit 2250 includes first and second drilling portions 2258, 2260 having different diameters corresponding to the transverse member. The drill bit 2250 includes a cylindrical bearing portion 2262 sized to fit the internal diameter of the drill sleeve 2200 in smooth rotational and axial sliding engagement. The drill bit 2250 includes a plurality of depth markings 2264. With the drill bit 2250 positioned within the drill sleeve 2200, the depth markings 2264 may be read adjacent the proximal end 2204 of the drill sleeve 2200. The depth markings 2264 are calibrated to indicate the distance from the distal end 2254 of the drill bit 2250 to the outer surface of the tunnel guide rod 2150. The indicated distance may be used in selecting a transverse member of the appropriate length for a particular patient.

The transverse bone hole access cannula 2300 includes a proximal body 2302 having an internal bore 2304 (FIG. 32) sized to slidingly engage the distal end 2206 of the drill sleeve 2200. The access cannula 2300 includes a distal conical extension 2306 terminating in a reduced diameter distal end 2308. The conical extension 2306 is divided by a plurality of slits 2310 into expandable petals 2312. The petals 2312 are flexible and permit the distal end 2308 of the cannula 2300 to expand from a first dimension engageable with the transverse bone hole to a second dimension (FIG. 32) sufficiently large to allow instruments and/or the transverse member to pass through the cannula 2300. With the petals 2312 fully collapsed, the access cannula 2300 forms a reduced diameter opening 2309 at its distal end 2308 that is sized to permit the suture passing pin 900 to pass through. The distal end 2308 of the cannula 2300 includes radially outwardly extending projections 2314 for engaging the transverse bone hole to secure the cannula 2300 in place. The projections 2314 may be in the form of threads, barbs, ribs, teeth, and/or other suitable projections. A handle 2316 extends radially outwardly from the proximal body 2302 to facilitate manipulation of the cannula 2300. Referring to FIG. 32, the assembled drill sleeve interface 2110, drill sleeve 2200, and transverse bone hole access cannula 2300 are illustrated. The cannula 2300 is shown positioned proximally on the drill sleeve with the proximal body 2302 abutting the drill sleeve interface 2110. In this position, the drill sleeve 2200 extends into the distal conical extension 2306 and presses the petals 2312 outwardly so that the cannula 2300 is expanded sufficiently large to allow instruments and/or the transverse member to pass through the cannula 2300. By sliding the cannula 2300 distally, the drill sleeve 2200 is withdrawn from the distal conical extension 2306 such that the petals 2312 collapse inwardly to facilitate insertion into the transverse bone hole. The cannulae may be made of metal, plastic, and/or other suitable materials. Exemplary plastics include polyethylene, acrylonitrile butadiene styrene, polyamides, polyaryletherketone, polytetrafluroethylene, and other suitable polymers.

FIG. 33 illustrates an alternative arrangement for a transverse bone hole access cannula 2350 and drill guide base 2100. This illustrative cannula 2350 includes an expandable conical extension 2352 and ribs 2354 adjacent the distal end 2356. In addition, one or more rails 2358 extend longitudinally from the proximal end 2360 of the cannula 2350 to increase the cannula 2350 working length. The rails 2358 extend the overall length of the cannula 2350 to accommodate use in a deep surgical wound. In such a case the cannula 2350 may be buried in the wound with the rails 2358 extending proximally to maintain access to the bone hole and to provide a grip for removing the cannula 2350 from the wound. One or more grooves 2114 corresponding to the rails 2358 are formed in the drill sleeve interface 2110 to receive the rails 2358 in sliding relationship. The rail and groove configuration permits the cannula 2350 to nest on the drill sleeve interface 2110 such that the cannula extends from the interface 2110 a distance less than the overall length of the cannula and rails. In the nested configuration, the proximal end of the cannula 2360 is adjacent the distal portion 2116 of the drill sleeve interface 2110 and the rails 2358 lie in the grooves 2114. The nested configuration increases the throat depth of the drill guide assembly and facilitates initial positioning of the guide adjacent to a surgical site. A grip 2362 is formed at the end of the rails 2358 to facilitate insertion and removal of the cannula 2350. In the illustrative instrument, the grip 2362 is formed as a semicircular ring connecting the ends of a pair of rails 2358. The semicircular ring slides over the top of the drill sleeve interface 2110 to permit the rails to nest on the interface 2110. A user may press against the grip 2362 to slide the cannula distally and into engagement with the transverse bone hole. The drill guide base 2100 of FIG. 33 also includes an “S”-shaped bend 2118 that moves the drill sleeve interface 2110 proximally to further increase the throat depth of the drill guide.

FIG. 34 illustrates an alternative arrangement for a transverse bone hole access cannula 2400. This illustrative cannula 2400 includes a body 2402 having a proximal end 2404, a distal end 2406 and an axial through bore 2408 extending from the proximal end 2404 to the distal end 2406. The bore 2408 has a constant diameter and is sized to fit over the drill sleeve 2200. Thus, instruments and/or cross-pins that pass through the drill sleeve 2200 may pass through the cannula 2400. The cannula 2400 includes a chamfer 2410 adjacent the distal end 2406 that tapers to a sharp edge at the distal end 2406. The chamfer 2410 permits the cannula 2400 to be impacted into the bone adjacent the transverse bone hole 1900. A longitudinal slot 2412 may optionally be provided to permit the cannula 2400 to be positioned over the drill sleeve 2200 laterally after the drill guide has already been mounted on the bone. An optional handle 2414 may also be provided.

FIG. 35 illustrates a transverse member alignment instrument 2500. The illustrative alignment instrument 2500 corresponds to the cross-pin 14 configuration of the transverse member shown in FIG. 1. The alignment instrument 2500 includes a proximal end 2502, a distal end 2504, and an axis extending therebetween. A handle 2506 is positioned adjacent the proximal end 2502. The distal portion of the instrument includes a small diameter cylindrical section 2510 corresponding to the distal cylindrical section 100 of the cross-pin 14, a shoulder 2512 corresponding to the tapered transition section 104 of the cross-pin 14, and a proximal cylindrical section 2514 sized for a slip fit within the transverse bone hole 1900 (FIG. 44). The small diameter cylindrical section 2510 is shorter than the distal cylindrical section 100 of the cross-pin 14 such that the alignment instrument 2500 may be inserted into the transverse bone hole and the proximal cylindrical section 2514 engaged with and centered within the transverse bone hole before the small diameter cylindrical section 2510 engages the graft block 12 aperture 40. The alignment instrument 2500 includes an axial through bore 2516 to permit a pin, suture, or other guide member to be passed through the alignment instrument 2500.

FIGS. 36-43 depict alternative illustrative configurations of the transverse member in the form of cross-pins. FIGS. 36-38 illustrate a cross pin 2600 similar to the cross pin 14 of FIG. 1. The cross pin 2600 includes a distal cylindrical section 2601, a proximal cylindrical section 2602, a tapered transition section 2604 between the two cylindrical sections, and a tapered distal end 2606 terminating in a pointed distal tip 2608. The proximal end 2610 of the cross pin 2600 is provided with a driver engagement portion in the form of a recess 2612. The proximal cylindrical section 2602 may be provided with a retention means as previously mentioned. The illustrative embodiment of FIGS. 36-38 includes radially extending ribs or fins 2614 that grip the transverse bone hole 1900 as the cross pin 2600 is advanced axially into the transverse bone hole 1900. An eyelet 2616 is formed near the distal tip 2608 to receive a suture, wire, or other guide member 2618 (FIG. 37) to aid in guiding the cross pin 2600 into engagement with the graft block 12. A channel 2620 is formed longitudinally in the outer surface of the proximal cylindrical section 2602 to receive the guide member 2618 as it extends proximally. The channel 2620 permits the guide member 2618 to lie below the surface of the proximal cylindrical section 2602 so that it may slide freely without being trapped between the cylindrical section 2602 and/or fins 2614 and the transverse bone hole 1900 wall. Thus, the cross pin 2600 may be advanced along the guide member 2618 and into engagement with the graft block 12.

A driver 2650 includes an elongate shaft 2652 having a distal projection 2654 sized to engage the recess 2612 of the cross pin 2600. The driver 2650 may be used to press and/or impact the cross pin 2600 into the transverse bone hole 1900. The driver may include an axial through bore 2656 and/or a longitudinal channel 2658 for optionally receiving the guide member 2618.

FIGS. 39 and 40 depict an alternative illustrative configuration of the cross pin of FIGS. 36-38. This cross pin 2750 further includes a longitudinal slot 2752 extending from the eyelet 2616 to the distal tip 2608. The cross pin 2750 further includes an opening 2754 communicating from the channel 2620 to the driver engaging recess 2612. The slot 2752 and opening 2754 allow the guide member 2618 to more nearly lie along the longitudinal axis of the cross pin 2750. Furthermore, a stopper 2756 may be provided on the guide member 2618 that is too large to pass through the opening 2754 to maintain the guide member aligned with the cross pin 2750 axis. The stopper 2756 may also prevent the guide member 2618 from inadvertently pulling through the cross pin 2750 while still allowing the cross pin 2750 to slide proximally along the guide member 2618. The stopper 2756 may be a knot, crimp, bead, or other suitable feature.

FIG. 41 depicts an alternative illustrative configuration for the distal tip 2802 of a cross pin 2800. The tip 2802 includes one or more angled slots 2804 to receive a looped guide member 2806. The looped guide member 2806 may be tensioned to orient the distal tip 2802 of the cross pin 2800 as it is inserted.

FIG. 42 depicts an alternative illustrative configuration for the distal tip 2852 of a cross pin 2850 similar to that of FIG. 40. In this configuration, the one or more angled slots 2854 are “J”-shaped to better retain the guide member 2856 should it be allowed to go slack momentarily. The curvature of the slot 2854 makes it more difficult for the guide member 2856 to slide out.

FIG. 43 depicts an alternative illustrative configuration for the distal tip 2902 of a cross pin 2900. In this configuration, the distal tip 2902 includes a rotating attachment mechanism. In the illustrative tip 2902, the mechanism includes a threaded recess 2904 formed into the distal tip 2902 for receiving a threaded stud 2906 formed on an end of a guide member 2908. The gender of the attachment mechanism may be reversed and other rotational attachment mechanisms may be substituted. For example, a quarter turn or bayonet style attachment mechanism may be used. The guide member 2908 may include an elongated unitary body having one end threaded or it may include a first, elongate member and a second, threaded member crimped, sewn, looped, or otherwise attached to the first member.

FIGS. 44-50 show an illustrative technique for using the instruments and implants according to the present invention. Referring to FIG. 44, tibial and femoral bone tunnels 1850, 1902 are drilled as previously described. For example, the tunnels may be formed by drilling over a guide wire 900 with a cannulated drill bit 550 to a predetermined depth (FIG. 15). The drill bit 550 is removed leaving the guide wire 900 in place. An incision 1904 is made on the lateral side of the thigh and extended down to the lateral femoral cortex 1906. The tunnel guide rod 2150 is assembled to the base 2100. The access cannula 2300 is assembled over the drill sleeve 2200 (FIG. 44) and slid proximally to expand the distal conical extension 2306. The assembly is applied to the knee by inserting the tunnel guide rod 2150 over the guide wire 900 and into the tibial and femoral tunnels 1850, 1902. The guide wire 900 is removed. The transverse drill bit 2250 is advanced through the drill sleeve 2200, access cannula 2300, and incision 1904 until the distal end 2254 of the drill bit 2250 contacts the lateral femoral cortex 1906. The depth markings 2264 on the drill bit 2250 may now be read adjacent the proximal end 2204 or the drill sleeve 2200 to indicate the distance from the distal end 2254 of the drill bit 2250 to the lateral edge 1910 of the femoral graft tunnel 1902.

The drill bit 2250 is now advanced to form the transverse bone hole 1900 from the lateral femoral cortex 1906 to intersect the femoral graft tunnel 1902 (FIG. 45). The transverse drill bit 2250 is withdrawn while simultaneously advancing the access cannula 2300 distally. As the distal conical extension 2306 is advanced off of the drill sleeve 2200 and the larger diameter portion 2260 of the transverse drill bit 2250 is withdrawn from the transverse bone hole 1900, the petals 2312 of the access cannula 2300 collapse inwardly around the reduced diameter portion 2258 of the transverse drill bit 2250. The distal conical extension 2306 can then be pressed into the lateral bone hole 1900 to maintain the location of the lateral bone hole 1900 (FIG. 46). Alternatively, if the chamfered access cannula of FIG. 34 is used, it may be impacted into the lateral bone hole 1900 before withdrawing the transverse drill bit 2250. A suture passing pin, which may be the same guide wire 900 used initially, is passed through the tunnel guide rod 2150 and into the femur. The transverse drill guide assembly is then removed (FIG. 47). The suture passing pin 900 is passed completely through the femur to pass one or more sutures 65 or other elongated members to be used to lift the graft block 12 into position. The graft block 12 is lifted into position.

Referring to FIG. 48, the suture passing pin 900 is next inserted through the access cannula 2300, through the graft block aperture 40, and out the medial side 1910 of the knee. The suture passing pin 900 is used to pass a guide member 2618 that is attached to a transverse member such as those shown in FIGS. 36-43. In the illustrative example of FIG. 48, the guide member 2618 is threaded through an eyelet 2616 in the end of a cross pin 2600 and both ends of the guide member 2618 are pulled through the graft block 12. Any of the guide member attachment arrangements of FIGS. 36-43 may be used. In the configuration of FIG. 43, the transverse member is attached directly to a guide member 2908 in the form of a pin.

A driver 2650 is engaged with the cross pin 2600 and used to push the cross pin 2600 into the access cannula 2300 (FIG. 49). The guide member 2618 is tensioned to guide the tip of the cross pin 2600 as the driver 2650 pushes it through the aperture 40 of the graft block 12. As the cross pin 2600 engages the conical extension 2306, the access cannula 2300 is withdrawn from the transverse bone hole 1900 to allow the petals 2312 to expand and the cross pin 2600 to pass. The cross pin 2600 is seated in the transverse bone hole 1900 and the graft passing suture 65 and guide member 2618 are withdrawn (FIG. 50). In the illustrative example of FIG. 49, they may be removed by pulling on one end of each such that they pull through the graft block and cross pin eyelets 42, 2616 respectively. In the configuration of FIG. 40, the guide member 2618 is pulled proximally to free the stopper 2756 and remove the guide member 2618. In the configuration of FIG. 43, the guide member 2908 is rotated to disengage it from the cross pin 2900.

Optionally, the transverse member alignment instrument 2500 of FIG. 35 may be used to align the graft block aperture 40 with the transverse bone hole 1900. The transverse member alignment instrument 2500 is slipped into the transverse bone hole 1900 in place of the access cannula 2300 and advanced until the cross pin alignment instrument 2500 seats in the graft block 12. The suture passing pin 900 may then be passed through the axial bore 2516 of the transverse member alignment instrument 2500 to position it through the graft block 12. The transverse member alignment instrument 2500 is then removed. Optionally, an arthroscope may be used to visually verify that the suture passing pin 900 passes through the graft block aperture 40. The guide member 2618 may be passed and the transverse member seated as described above.

As shown in FIG. 50, once the transverse member 2600 is seated, the graft 59 is tensioned and fixed to the tibia 1912. For example, an interference screw 1914 may be driven adjacent the graft 59 to retain the graft 59 in the tibial bone tunnel 1850.

In addition to the advantages already stated, the present invention offers other advantages in connecting grafts to bone. One such advantage is that the graft block may be configured to enable the surgeon to pull straight on the end of the graft in order to draw it into the bone tunnel. This pulling direction provides the greatest leverage. The ability to pull straight on the graft in a direction aligned with the graft enables the surgeon to form the bone tunnel with as small a diameter as possible in order to produce a more intimate fit between the graft and the wall of the bone tunnel.

Another advantage of the invention is that the large pin receiving aperture enables the placement of a transverse pin through the graft block in one step and without a guide wire or the need for X-ray visualization.

Another advantage of the invention is that it permits delicate handling of the graft and its secure attachment to the graft block outside of the body where it can be visualized and handled with ease. The blind attachment of the graft block/graft assembly within the bone tunnel involves connecting two easily manipulated, robust, positively engaging pieces with little chance for damage to the graft or a partial attachment.

It will be understood by those skilled in the art that numerous improvements and modifications may be made to the preferred embodiment of the invention disclosed herein without departing from the spirit and scope thereof. 

1. A drill guide assembly for drilling a hole in a bone and for maintaining alignment with said hole, the assembly comprising: a drill having a first drill diameter; a drill sleeve having an inner bore sized to receive the first drill diameter of the drill in sliding relationship; a cannula slidingly engageable with the drill sleeve, the cannula having an inner bore and an outer sidewall, the cannula being slidably disengagable from the drill sleeve such that it may be disengaged from the drill sleeve to maintain the location of the hole in the bone.
 2. The drill guide assembly of claim 1 wherein the cannula further comprises a chamfered distal tip engageable with the hole in the bone.
 3. The drill guide assembly of claim 1 wherein the cannula further comprises a longitudinal slot formed radially outwardly from the inner bore to the outer sidewall, the slot being at least as wide as the drill sleeve to permit the cannula to be placed radially onto the drill sleeve.
 4. The drill guide assembly of claim 1 wherein the cannula further comprises a resilient and tapered distal tip defining a tapered inner bore, the distal-most portion of the distal tip being resiliently expandable from a first distal tip inner diameter to a second distal tip inner diameter upon being slidingly received by the drill sleeve, the second distal tip inner diameter being greater than or equal to the first drill diameter.
 5. The drill guide assembly of claim 4 wherein the distal tip of the cannula includes a plurality of longitudinal slits forming a plurality of resilient petals movable radially inwardly and outwardly between the first distal tip inner diameter and the second distal tip inner diameter.
 6. The drill guide assembly of claim 4 wherein the drill sleeve includes an outer diameter equal to the inner diameter of the tapered inner bore at a point situated longitudinally a predetermined distance proximally of the distal-most tip of the cannula, such that when the distal end of the drill sleeve is positioned closer to the distal-most tip of the cannula than the predetermined point, the distal-most portion of the cannula is expanded.
 7. The drill guide assembly of claim 4 wherein the drill further comprises a second drill diameter located distally from the first drill diameter, the second drill diameter being smaller than the first drill diameter to create a shoulder between the first and second drill diameters, the cannula being slidable from the drill sleeve onto the drill and along the drill with the distal-most portion of the cannula being biased inwardly against the drill to conform to the diameter of the portion of the drill upon which it is placed.
 8. The drill guide assembly of claim 1 further comprising a drill guide base member having a drill sleeve mounting portion for receiving the drill sleeve, the drill sleeve mounting portion including one or more grooves and the cannula further comprising one or more longitudinal rails extending proximally from the cannula and engageable with the one or more grooves, the rails being slidably engageable with the grooves.
 9. The drill guide assembly of claim 8 wherein the rails are slideable within the grooves to move the cannula between a first position in which the cannula is spaced from the drill sleeve mounting portion and a second position in which the cannula is adjacent the drill sleeve mounting portion such that in the second position the cannula extends from the drill sleeve mounting portion a distance less than combined length of the cannula and rails.
 10. The drill guide assembly of claim 8 further including a grip formed at the end of the rails, the grip forming a semicircular ring connecting the ends of a plurality of rails.
 11. The drill guide assembly of claim 1 wherein the cannula includes radially extending projections engageable with the hole in the bone.
 12. The drill guide assembly of claim 1 wherein the cannula is made of one or more biocompatible polymers.
 13. The drill guide assembly of claim 1 wherein the cannula is made of one or more materials selected from the group consisting of polyethylene, acrylonitrile butadiene styrene, polyamides, polyaryletherketone, and polytetrafluroethylene.
 14. The drill guide assembly of claim 1 further comprising: a drill guide having a tunnel guide rod for insertion into a first bone tunnel, the tunnel guide rod being connected to the drill sleeve transversely to the drill sleeve, the drill having a distal end and a plurality of depth markings, the depth markings indicating the distance from the distal end of the drill to the outer surface of the tunnel guide rod when the drill is positioned within the drill sleeve.
 15. A transverse member alignment instrument for use with a transverse member having a distal portion including a first cylindrical portion, a proximal portion having a second cylindrical section having a diameter larger than the first cylindrical section, and a shoulder formed between the first and second cylindrical sections, the transverse member being transversely engageable with a graft block to maintaining a ligament in a bone tunnel, the transverse member alignment instrument comprising: a distal portion including a first cylindrical section corresponding to the transverse member; a proximal portion having a second cylindrical section having a diameter larger than the first cylindrical section corresponding to the transverse member; a shoulder formed between the first and second cylindrical sections corresponding to the transverse member; and a handle formed adjacent to the proximal portion.
 16. The transverse member alignment instrument of claim 15 wherein the first cylindrical section of the transverse member alignment instrument is shorter than the first cylindrical section of the transverse member.
 17. The transverse member alignment instrument of claim 15 wherein the transverse member alignment instrument includes an axial through bore.
 18. A transverse member for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel, the transverse member comprising: a distal portion having an axis, a distal end, a proximal end, and an outer surface; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole by pushing the transverse member axially into the transverse bone hole; an eyelet formed transversely through the distal portion.
 19. The transverse member of claim 18 further comprising at least one longitudinal channel formed in the surface of the proximal portion and extending along a portion of the proximal cylindrical.
 20. The transverse member of claim 18 further comprising at least one longitudinal slot formed in the surface of the distal portion and extending proximally from the eyelet.
 21. A transverse member for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel, the transverse member comprising: a distal portion having an axis, a distal end, a proximal end, and an outer surface; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole; and a slot formed in the distal portion, the slot angling distally from the outer surface of the distal portion toward the axis.
 22. The transverse member of claim 21 wherein the slot is “J”-shaped.
 23. A transverse member for retaining a graft in a bone tunnel by being positioned in a bone hole transverse to the bone tunnel, the transverse member comprising: a distal portion having an axis, a distal end, a proximal end, and an outer surface, the distal portion being threaded adjacent the distal end; a proximal portion having an axis, a distal end, a proximal end, and an outer surface, the proximal portion including outwardly extending projections engageable with the transverse bone hole; and a guide member including an elongated body having a first end, a second end, and an axis extending therebetween, the guide member being threaded adjacent the first end, the first end being threadingly engageable with the distal portion.
 24. A method of forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel, the method comprising: forming a graft tunnel in the bone; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and positioning a second leg outside of the bone, the second leg having a transverse drill sleeve directed transverse to the graft tunnel; mounting a cannula on the drill sleeve in sliding relationship; guiding a drill bit with the drill sleeve to form a transverse bone hole intersecting the graft tunnel; and advancing the cannula into engagement with the transverse bone hole to maintain access to the transverse bone hole upon removal of the drill guide.
 25. The method of claim 24 wherein the cannula includes an expandable portion having a first collapsed diameter and a second expanded diameter larger than the collapsed diameter, the method further comprising: expanding the cannula to the second expanded diameter by sliding the cannula onto the drill sleeve; and withdrawing the drill bit from the drill sleeve while simultaneously sliding the cannula along the drill sleeve and into the transverse bone hole so that the expanding portion collapses to the first collapsed diameter and engages the transverse bone hole.
 26. The method of claim 24 wherein the cannula includes a chamfered end, the method further comprising: sliding the cannula longitudinally along the drill sleeve until the chamfered end is adjacent the transverse bone hole; and pressing the chamfered end into engagement with the transverse bone hole.
 27. The method of claim 24 wherein the cannula includes a longitudinal slot permitting the cannula to be radially inserted onto the drill sleeve by advancing the cannula sideways over the drill sleeve, the cannula further including, the method further comprising: advancing the cannula sideways over the drill sleeve; and sliding the cannula longitudinally along the drill sleeve and into engagement with the transverse bone hole.
 28. A method of forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel, the method comprising: forming a graft tunnel in the bone; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and positioning a second leg outside of the bone, the second leg having a transverse drill sleeve directed transverse to the graft tunnel; advancing a drill transversely along the drill sleeve axis until the distal end of the drill contacts the outer surface of the bone; reading indicia on the drill bit to determine the distance from the outer surface of the bone to the graft tunnel; and advancing the drill bit into the bone to form a transverse bone hole intersecting the graft tunnel.
 29. A method of inserting a transverse member in a transverse bone hole to intersect a graft tunnel to secure a graft in the tunnel, the method comprising: inserting a guide member through the transverse bone hole and across the graft tunnel; engaging an inserter with a proximal end of a transverse member; and pushing the transverse member into the transverse bone hole while simultaneously tensioning the guide member to guide the tip of the transverse fixation member across the graft tunnel.
 30. The method of claim 29 wherein the graft is secured to a graft block having a transverse aperture aligned with the transverse bone hole, the method further comprising: pushing the transverse member into engagement with the graft block while simultaneously tensioning the guide member to guide the tip of the transverse fixation member through the graft block aperture.
 31. A method of securing a graft in a graft tunnel, the graft being attached to a graft block having a transverse aperture alignable with a transverse bone hole, the graft block being fixed in the graft tunnel by a transverse member insertable along the transverse bone hole and through the aperture to suspend the graft block and graft in the graft tunnel, the method comprising: providing a transverse member alignment instrument; inserting the transverse member alignment instrument along transverse bone hole and into engagement with the graft block aperture; removing the transverse member alignment instrument; and inserting the transverse member into engagement with the graft block.
 32. The method of claim 31 wherein the transverse member alignment instrument includes a longitudinal through bore, the method further comprising: inserting a guide member through the longitudinal through bore of the transverse member alignment instrument, through the graft block, and out of the bone; and removing the cross pin alignment instrument leaving the guide member in place.
 33. The method of claim 32 further comprising: inserting a viewing scope through the transverse bone hole to visually verify that the guide member passes through the graft block aperture.
 34. The method of claim 31 further comprising: pressing the transverse member into engagement with the graft block while simultaneously tensioning the guide member to guide the tip of the transverse fixation member through the graft block aperture.
 35. A method of forming a transverse bone hole to intersect a main graft tunnel for inserting a transverse fixation member to secure the graft in the tunnel, the method comprising: inserting a guide wire into a bone along the desired path of a graft tunnel for receiving a ligament graft; forming a graft tunnel in the bone by advancing a cannulated drill over the guide wire; mounting a transverse tunnel drill guide by placing a first leg of the drill guide inside the graft tunnel and extending a second leg along the outside of the bone parallel to the first leg; directing a drill sleeve mounting on the second leg transversely toward the graft tunnel; mounting a cannula on the drill sleeve in sliding relationship; advancing a drill transversely along the drill sleeve axis until the distal end of the drill contacts the outer surface of the bone; reading indicia on the drill bit to determine the distance from the outer surface of the bone to the graft tunnel; advancing the drill bit into the bone to form a transverse bone hole intersecting the graft tunnel; advancing the cannula into engagement with the transverse bone hole to maintain access to the transverse bone hole upon removal of the drill guide; inserting a suture passing pin through the first leg of the drill guide, along the graft tunnel, and through the bone along the graft tunnel axis; removing the drill guide; threading a graft passing suture up through the graft tunnel and out of the bone using the suture passing pin; lifting the graft into the graft tunnel using the sutures; inserting a guide member through the access cannula, through the graft block; and out of the bone; engaging an inserter with the proximal end of the transverse fixation member; and pushing the transverse fixation member into the transverse bone hole while simultaneously tensioning the guide member to guide the tip of the transverse fixation member through the graft block. 